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. 2025 Sep 12:14:1015-1028.
doi: 10.2147/ITT.S538796. eCollection 2025.

Clinical Outcomes and Hepatic Toxicity of Combined Intensity Modulated Radiotherapy and PD-1 Inhibitors in Child-Pugh Class B Advanced Hepatocellular Carcinoma

Lijun Chen  1 , Min Liu  2 , Shenshen Chen  1 , Yi Wu  1 , Shichun Guan  1 , Jianxu Li  1 , Shixiong Liang  1
Affiliations

Clinical Outcomes and Hepatic Toxicity of Combined Intensity Modulated Radiotherapy and PD-1 Inhibitors in Child-Pugh Class B Advanced Hepatocellular Carcinoma

Lijun Chen et al. Immunotargets Ther. .

Abstract

Purpose: There is limited research data on the management of hepatocellular carcinoma (HCC) patients with Child-Pugh class B (CP-B). This study aimed to evaluate the clinical outcomes and radiation-induced hepatic toxicity (RIHT) of combined intensity modulated radiotherapy (IMRT) and programmed cell death protein 1 (PD-1) inhibitors in advanced HCC patients with CP-B.

Patients and methods: This retrospective study screened 232 CP-B advanced HCC patients who had undergone IMRT, and the irradiation scopes were intrahepatic tumor lesions and/or venous tumor thrombosis. The propensity matching method (PSM) was used to reduce selection bias between the radiotherapy (RT) and RT+PD-1 groups. The primary endpoints were overall survival (OS) and progression-free survival (PFS), and the secondary endpoints included local progression-free survival (LPFS), out-of-field progression-free survival (outPFS), objective response rate (ORR), disease control rate (DCR), and RIHT.

Results: 50 and 39 patients with CP-B advanced HCC were included in the RT+PD-1 and RT groups. After PSM, 39 patients from each group were matched. The median follow-up duration was 15.53 months (95% CI, 13.83-17.22). The median OS and median PFS of RT+PD-1 group were significantly prolonged than RT group (OS:14.27 months [95% CI, 10.53-not estimable] vs 7.57 months [95% CI, 6.57-10.00], HR = 0.284; 95% CI, 0.153-0.526; p < 0.001), (PFS:9.00 months [95% CI, 5.00-not estimable] vs 4.50 months [95% CI, 3.10-6.00], HR = 0.349; 95% CI, 0.188-0.648; p < 0.001). The ORR of RT+PD-1 group was improved than RT group, 43.6% (95% CI, 27.3-59.9) vs 28.2% (95% CI, 13.4-43.0) (p = 0.157). The incidence of RIHT did not differ between the groups except the RT+PD-1 group experienced increased total bilirubin (≥grade 1) more frequently (p = 0.021).

Conclusion: Combined IMRT and PD-1 inhibitors improved clinical outcomes with a comparable incidence of RIHT to radiotherapy alone in advanced HCC patients with CP-B. The individual combined IMRT and PD-1 inhibitors for CP-B could be cautiously applied weighing the survival benefits and the RIHT risks.

Keywords: Child-Pugh B; PD-1 inhibitors; hepatic toxicity; hepatocellular carcinoma; immunotherapy; radiotherapy.

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Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Flowchart of patient selection.
Figure 2
Figure 2
Kaplan−Meier curves for (A) overall survival and (B) progression-free survival.
See this image and copyright information in PMC

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